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Acetaminophen

Bonita Pharmaceuticals LLC
Bonita Pharmaceuticals LLC

Extra Strength Acetaminophen 500mg Caplets




FULL PRESCRIBING INFORMATION

(in each caplet)

Acetaminophen 500mg

Pain reliever/Fever reducer

For the temporary relief of minor aches and pains due to:

  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps

Temporarily reduces fever.

Liver warning:

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000mg) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

liver disease.

taking the blood thinning drug warfarin.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is pressent

These could be signs of a serious condition.

ask a health professional before use.

Keep out of reach of children.

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Do not take more than directed (see overdose warning)

Adults and children 12 years and over:

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

Children under 12 years: ask a doctor

  • Do not use if imprinted safety seal under cap is broken or missing
  • Store at room temperature
  • Povidone
  • Pregelatinized Starch
  • Sodium Starch Glycolate
  • Stearic Acid

If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.

Acetaminophen

Image 1 : Extra Strength Acetaminophen 500mg, 1000ct caplets

Acetaminophen

Image 2 : Extra Strength Acetaminophen 500mg, 100ct caplets

Acetaminophen

Acetaminophen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53598-003
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg

Inactive Ingredients

Ingredient Name Strength
povidone
STARCH, PREGELATINIZED CORN
sodium starch glycolate type a corn
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
white 17 mm GPI;A5 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53598-003-01 100 in 1 BOTTLE, PLASTIC
2 NDC:53598-003-10 1000 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-04-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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